Philips Healthcare is voluntarily recalling some of its HeartStart FR2+ automated external defibrillators (AED), with the knowledge of the appropriate regulatory agencies.
The devices may contain a memory chip that has a higher than expected rate of failure, according to the company.
“Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated,” Philips warned.
In all cases reported to date, the problem has been detected by the FR2+ during a periodic self-test or a battery insertion test. The company also said that there have been “no reported incidents of the problem during emergency use of the AED, and no injuries to users or patients.” Philips said it is retrieving units that “may contain the defective chips.”
Affected devices are models M3840A and M3841A (distributed by Laerdal Medical), and M3860A and M3861A (distributed by Philips). The units affected by the recall were manufactured by Philips between May 2007 and January 2008.